The 15 new EU modules concerning Pharmacovigilance are a major departure
in terms of the way Pharmacovigilance is conducted in Europe. The
intention of the course is to look at these modules and their
requirements, examine how they overlap and fit together and what
Companies need to do in terms of their legal requirements; training;
changes and introduction of SOPs; and the links to other Departments -
not just Pharmacovigilance but also including Clinical; Medical
Information; Marketing; IT; Quality; Regulatory; Training and GMP.

This course will also examine how the new modules have been
revised since 2012

Gain an Invaluable Overview of the New European PV Legislation and How
the 15 Modules Link Together

Discover what Key Areas of Pharmacovigilance Activities have been
Affected

Understand the Impact of the Legislation and what you will need to do
to Implement in your Company

Discuss the Enforcement of the Legislation and what the Regulators
will expect to see at Inspection Time

See what NEW Company Departments are Affected Under the New Legislation

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